Effect of Telitacicept on Antibody Titers in Primary APS Patients

A Single Center, Randomized Controlled, Open Trial Exploring the Regulatory Effect of Telitacicept on Antibody Titers in Primary Antiphospholipid Syndrome Patients Carrying High-risk Antiphospholipid Antibody Profiles

The purpose of this study is to evaluate the regulatory effect of Telitacicept on antibody titers in primary antiphospholipid syndrome patients carrying high-risk antiphospholipid antibody profiles.

Study Overview

• Status: Recruiting
• Conditions: Antiphospholipid Syndrome (APS)
• Intervention / Treatment: Drug: Telitacicept; Drug: SOC

Detailed Description

This is a single center, randomized controlled trial in Ruijin Hospital. The enrolled patients will be randomized in a 1: 1 ratio to receive either SOC+Telitacicept or SOC treatment.Telitacicept is administered subcutaneously at a dose of 160mg once a week for 48 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chengde Yang, Dr; Phone Number: 008613501717833; Email: yangchengde@sina.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital
      • Contact: Phone Number: 0086-0021-64370045
      • Principal Investigator: Chengde Yang, Dr
      • Sub-Investigator: Hui Shi, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ≥18 years;
• Diagnosis of primary APS, meet 2006 Sydney classification criteria or continuously positive for antiphospholipid antibodies within the first 12 months of inclusion (tested at least every 12 weeks), classified as high-risk antiphospholipid antibody spectrum based on the risk of antibody levels, in order to meet at least one of the following conditions: 1. Positive lupus anticoagulant (LAC) (tested according to ISTH guidelines); 2. Two or three types of aPL positivity (lupus anticoagulant, anticardiolipin antibody, and anti-β2 any two or all three types of glycoprotein I antibodies; 3. Or persistent high titer aPL;
• There are no other autoimmune diseases occurring simultaneously;
• According to EULAR recommendations for antiphospholipid syndrome, a stable APS treatment regimen should be adopted;
• Female patients who are not pregnant, breastfeeding, have no fertility potential, or have not undergone contraception.

Exclusion Criteria:

• Patients with a history of malignant tumor in the past 5 years, except for basal cell carcinoma or squamous cell carcinoma of skin or cervical carcinoma in situ treated locally, and there is no evidence of metastasis within 3 years;
• Patients with a history of primary immunodeficiency;
• Serious lack of IgG (IgG level < 400 mg/dL);
• IgA deficiency (IgA level < 10 mg/dL);
• Patients with a current history of infection;
• Patients with a current history of drug or alcohol abuse or dependence, or have a history of drug or alcohol abuse or dependence within 365 days before day 0;
• HIV test is historically positive or HIV screening is positive;
• Hepatitis status;
• Patients with a history of allergic reaction caused by injection of contrast agent, human or mouse protein or monoclonal antibody;
• Patients with other abnormal laboratory values with clinical significance;
• If women with reproductive potential (WCBP) are included, please refer to the following special instructions;
• Patients with concurrent major medical or mental illnesss;
• Patients with diseases of liver, kidney, heart and other important organs,blood and Endocrine system;
• Patients who have been vaccinated with live vaccine in the last month;
• Patients who have participated in any clinical trial within 28 days before the initial screening and/or within 5 times of the half-life of the study compound (whichever is longer);
• Patients who use B-cell targeted therapy drugs within one year, such as rituximab or epratuzumab;
• Patients who use tumor necrosis factor inhibitor and interleukin receptor blocker within one year;
• Patients who use Intravenous gamma globulin (IVIG) and prednisone ≥100mg/d for more than 14 days within one year or plasma exchange;
• Patients with active infection (such as herpes zoster, HIV infection, active tuberculosis, etc.) during the screening period;
• Patients with depression or suicidal thoughts;
• Other conditions that the investigator considers would make the candidate unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: SOC+Telitacicept arm; Telitacicept 160mg once a week for 48 week as an add-on treatment regimen. SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.	Drug: Telitacicept; 160mg once a week for 48 weeks; Drug: SOC; SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.
Active Comparator: Experimental: SOC arm; SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.	Drug: SOC; SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with decreased aPL titer at week 48 of treatment	week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
new thrombotic event	any new thrombotic event during Telitacicept treatment	48 weeks
Effects of Telitacicept on the genotype, phenotype, and functional heterogeneity of T and B cells	Application of single-cell RNA sequencing technology (scRNAseq)	baseline, week 12, 24, 36, 48

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence and severity of adverse events	Number and intensity of adverse events	48 weeks

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Telitacicept; Antiphospholipid Antibody Profiles
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Disease; Syndrome; Antiphospholipid Syndrome
• Other Study ID Numbers: sh12053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No